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Write-up: Vaccine breakthrough infection/ Vaccination failure; Influenza; Superinfection bacterial; This case was reported by a physician via regulatory authority and described the occurrence of vaccine breakthrough infection in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) (batch number AFLBA376BA, expiry date unknown) for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus, obstructive bronchitis, osteoporosis, chronic obstructive pulmonary disease and essential hypertension (Benign). On 30th September 2019, the patient received Influsplit Tetra 2019/2020 (intramuscular). On 17th February 2020, 140 days after receiving Influsplit Tetra 2019/2020, the patient experienced vaccine breakthrough infection (serious criteria death, hospitalization and GSK medically significant), influenza (serious criteria death and hospitalization) and superinfection bacterial (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccine breakthrough infection, influenza and superinfection bacterial were fatal. The reported cause of death was influenza, vaccine breakthrough infection and superinfection bacterial. It was unknown if the reporter considered the vaccine breakthrough infection, influenza and superinfection bacterial to be related to Influsplit Tetra 2019/2020. Additional details: The age at vaccination was not provided but the patient could be 70 years or less than 70 year old. As per the confirmation received, event- vaccine breakthrough infection was considered as vaccination failure and influenza as that of target disease. More information about the same, if any, is expected in follow up. Initial information was reported by a Physician via regulatory authority on 27th April 2020: influenza, vaccine breakthrough infection and superinfection bacterial.; Reported Cause(s) of Death: Influenza; Vaccine breakthrough infection; Superinfection bacterial
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